Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412913
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2024-04-30
Brief Title:
Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail
Sponsor:
Orthofix srl
Organization:
Orthofix srl
Study Overview
Official Title:
Multicenter Retrospective Observational Study to Assess the Clinical Performance and Safety Profile of MJ-FLEX in Paediatric Patients Who Have Suffered Diaphyseal Fractures of Long Bones in Daily Practice MJ-FLEX Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MJ-Flex
Brief Summary:
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the MJ-FLEX elastic nail used in pediatric patients according to the manufacturer Instructions For Use IFU in the time frame from the time of surgery until the last follow-up visit available at the hospitals
Detailed Description:
The study is planned to be conducted in two investigational sites one in France and one in United Kingdom both experienced in the treatment of pediatric patients with diaphyseal fractures in the clavicle and in upper and lower limbs where the usage of MJ-Flex The New Metaizeau Nail known as MJ-Flex was part of the normal clinical practice
Investigator of both study sites will provide data for a maximum of 61 patients meeting inclusion and exclusion criteria Considering a drop-out or a non-evaluable rate of 10 of the procedures that will contribute for approximately 61 procedures in which MJ-Flex was used
No diagnostic or therapeutic intervention outside of routine clinical practice will be applied The study has been designed to analyze medical records of patients where study data was collected as part of their routine clinical practice Therefore patients will be retrospectively enrolled in the study Patients who have undergone MJ-Flex implantation from 022018 to 122022 are considered for the study The observation period of study subjects will comprise from surgery until the last follow up visit available
Medical records of the participating sites are expected to contain all the required information
In United Kingdom no study visit will be required but according to local legislation it will be essential that before collecting any information from medical records participants or their guardians are asked for specific informed consent to be signed by them before any collection of patient information takes place
However in France due to the use of primary data and the foreseen exemption of the informed consent IC form see Section 142 Informed Consent no study visit will be required
Investigator of both study sites will provide data for a maximum of 61 patients meeting inclusion and exclusion criteria Considering a drop-out or a non-evaluable rate of 10 of the procedures that will contribute for approximately 61 procedures in which MJ-Flex was used
No diagnostic or therapeutic intervention outside of routine clinical practice will be applied The study has been designed to analyze medical records of patients where study data was collected as part of their routine clinical practice Therefore patients will be retrospectively enrolled in the study Patients who have undergone MJ-Flex implantation from 022018 to 122022 are considered for the study The observation period of study subjects will comprise from surgery until the last follow up visit available
Medical records of the participating sites are expected to contain all the required information
In United Kingdom no study visit will be required but according to local legislation it will be essential that before collecting any information from medical records participants or their guardians are asked for specific informed consent to be signed by them before any collection of patient information takes place
However in France due to the use of primary data and the foreseen exemption of the informed consent IC form see Section 142 Informed Consent no study visit will be required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 334519 | OTHER | IRAS project ID UK | None |